Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 207265
Company: HEC PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM EQ 40MG BASE CAPSULE, DELAYED REL PELLETS;ORAL Prescription AB No No
ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED REL PELLETS;ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/18/2018 ORIG-1 Approval STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/25/2019 SUPPL-1 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

ESOMEPRAZOLE MAGNESIUM

CAPSULE, DELAYED REL PELLETS;ORAL; EQ 40MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM EQ 40MG BASE CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 208333 ALKEM LABS LTD
ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM EQ 40MG BASE CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 205606 AUROBINDO PHARMA LTD
ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM EQ 40MG BASE CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 078279 DR REDDYS LABS LTD
ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM EQ 40MG BASE CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 207265 HEC PHARM
ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM EQ 40MG BASE CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 078003 IVAX SUB TEVA PHARMS
ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM EQ 40MG BASE CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 205563 LANNETT CO INC
ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM EQ 40MG BASE CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 078936 MYLAN PHARMS INC
ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM EQ 40MG BASE CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 209735 SUN PHARM INDS LTD
ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM EQ 40MG BASE CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 203636 TORRENT
NEXIUM ESOMEPRAZOLE MAGNESIUM EQ 40MG BASE CAPSULE, DELAYED REL PELLETS;ORAL Prescription Yes AB 021153 ASTRAZENECA PHARMS

CAPSULE, DELAYED REL PELLETS;ORAL; EQ 20MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 208333 ALKEM LABS LTD
ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 205606 AUROBINDO PHARMA LTD
ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 078279 DR REDDYS LABS LTD
ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 207265 HEC PHARM
ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 078003 IVAX SUB TEVA PHARMS
ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 205563 LANNETT CO INC
ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 078936 MYLAN PHARMS INC
ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 209735 SUN PHARM INDS LTD
ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 203636 TORRENT
NEXIUM ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED REL PELLETS;ORAL Prescription Yes AB 021153 ASTRAZENECA PHARMS

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